Isotretinoin recalls: 16 FDA reports
Recalls involving Isotretinoin. What was wrong with each batch, and how the FDA graded the risk.
16Reports
0Class I
5Ongoing
2026-04-29Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 bli
D-0521-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
- Product
- Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Where it went
- Nationwide in the USA, Puerto Rico and Virgin Islands
- How much
- 5,101 cartons
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals
D-0446-2026 · Class II · reported 2026-04-15 · Ongoing
- Why it was recalled
- Superpotent and Subpotent
- Product
- Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
- Where it went
- FL, OH, PR & MS
- How much
- 8376 packages
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals
D-0445-2026 · Class II · reported 2026-04-15 · Ongoing
- Why it was recalled
- Superpotent and Subpotent
- Product
- Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).
- Where it went
- FL, OH, PR & MS
- How much
- 21984 packages
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactur
D-0399-2026 · Class II · reported 2026-03-11 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
- Where it went
- Nationwide within the United States
- How much
- 34850 blister packs
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Phar
D-0439-2024 · Class II · reported 2024-04-17 · Ongoing
- Why it was recalled
- Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
- Product
- Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
- Where it went
- Nationwide in the USA
- How much
- 5,304 3x10-cartons
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. D
D-0321-2020 · Class III · reported 2019-11-20 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
- Product
- Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
- Where it went
- Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
- How much
- 2460 cartons/3 blister cards/10 capsules each
Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by:
D-1207-2019 · Class III · reported 2018-12-26 · Terminated
- Why it was recalled
- Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
- Product
- Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack)
- Where it went
- Nationwide in the USA
- How much
- 47,520 prescription packs
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufa
D-0884-2017 · Class II · reported 2017-06-14 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: out of specification results observed for low dissolution.
- Product
- Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 89,118 cartons
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufa
D-0883-2017 · Class II · reported 2017-06-14 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: out of specification results observed for low dissolution.
- Product
- Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 13,221 cartons
Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufa
D-0885-2017 · Class II · reported 2017-06-14 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: out of specification results observed for low dissolution.
- Product
- Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-113-81
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 223,650 cartons
Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufa
D-0886-2017 · Class II · reported 2017-06-14 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: out of specification results observed for low dissolution.
- Product
- Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-137-81
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 452,290 cartons
Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufa
D-0509-2017 · Class III · reported 2017-03-08 · Terminated
- Why it was recalled
- Failed dissolution specifications - low dissolution results at S3 stage.
- Product
- Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
- Where it went
- U.S. Nationwide
- How much
- 4404 cartons
Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufa
D-0506-2017 · Class III · reported 2017-03-08 · Terminated
- Why it was recalled
- Failed dissolution specifications - low dissolution results at S3 stage.
- Product
- Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India,NDC 55111-137-81
- Where it went
- U.S. Nationwide
- How much
- 4032 cartons
Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufa
D-0507-2017 · Class III · reported 2017-03-08 · Terminated
- Why it was recalled
- Failed dissolution specifications - low dissolution results at S3 stage.
- Product
- Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
- Where it went
- U.S. Nationwide
- How much
- 12132 cartons
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla
D-0098-2017 · Class III · reported 2016-10-19 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
- Where it went
- nationwide
- How much
- 3,858 prescription packs (115,680 capsules)
Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured fo
D-1288-2015 · Class II · reported 2015-08-12 · Terminated
- Why it was recalled
- Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
- Product
- Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.
- Where it went
- Nationwide
- How much
- 9,229 Boxes
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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